The present invention concerns a method and apparatus for percutaneous excisional breast biopsy and a percutaneous excisional breast biopsy device (PEBB device).
Currently, there is great emphasis on early diagnosis of breast cancer through the use of mammography since early intervention may substantially alter the course of the disease. Mammography is capable of detecting very small abnormalities, often nonpalpable, within the breast. However, mammography is usually unable to differentiate between malignant and benign lesions. Thus, the surgeon is confronted with the problem of biopsying these lesions.
The only method of making a definitive diagnosis of breast cancer is by histologic examination of the suspect tissue. There are essentially two techniques for obtaining a histologic diagnosis: open surgery biopsy and needle biopsy.
In surgical biopsy the suspect tissue is removed through a surgical incision. It can be performed under local or general anesthesia, preferably in a surgical suite. Surgical biopsies are either incisional (removal of only a part of the tumor) or excisional (removal of the entire gross tumor or lesion). Small lesions with a diameter about 1 cm or less are usually excised completely. Relative to needle biopsy, surgical biopsy has higher patient morbidity and costs.
A fine needle biopsy involves obtaining cytologic material through aspiration by a syringe and a needle. A cytologist will then examine the cytologic material. Core needle biopsy removes a small core of tissue through the use of various needles designed for this purpose (e.g., Travenol Tru-Cut needle). A pathologist will then remove and examine the suspect tissue. With core needle biopsy a definitive diagnosis is possible only if a positive diagnosis of malignancy is made. The disadvantage of core needle biopsy is that a negative finding is inconclusive because of the possibility of being a false negative. False negatives may be due to an inadequate sample or to the wrong site being sampled. A negative finding usually requires the performance of an open biopsy. Even a positive finding may require surgical excision if conservation therapy is to be employed. The use of needle biopsy is usually restricted to tumors larger than 2 mm in diameter. Needle biopsy of smaller, mobile lesions increases the chances of obtaining a false negative.
The present invention overcomes the disadvantages and shortcomings of the prior art and provides a method and device for percutaneous excisional breast biopsy.